The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 1.5mm Mini Fragment Lcp System.
| Device ID | K090047 |
| 510k Number | K090047 |
| Device Name: | SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-07 |
| Decision Date | 2009-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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